This invention concerns specimen collection and sampling containers for collection of liquid specimens, such as urine. At present, liquid specimens are usually collected in plastic or glass containers that may have a lid or cover to close the container. The specimens are then sent to a distant lab for analysis, or put aside until a technician is ready to initiate the analysis procedure. At the lab or testing site, portions of the sample are transferred from the collection container to other containers more suitable for use in analysis and storage of the sample such as test tubes. It is often desirable to split a specimen into several aliquots so that each aliquot may be tested for a different characteristic. For example, one aliquot may be tested for the presence of specific chemicals, enzymes, etc. and another may be tested for microorganism count or bacterial identity. Transfer of the sample from the collection container under sterile conditions is problematic. Such methods as pouring, pipetting and funneling the sample from the collection container to a test tube or other receptacle are often disadvantageous because the microbiological and chemical integrity of the original sample may be sacrificed if asceptic techniques are not followed. Additionally, the increased possibility of mislabeling occurs with each transfer leading to erroneous results for a particular patient.
Specimen collection is addressed in U.S. Pat. Nos. 4,116,066 and 4,300,404 both to Mehl, et al. Devices providing a cannula attached to a collection container and to the lid through which fluid can be transferred from the container to a separate evacuated tube are disclosed therein. These apparatus reduce the possibility of spillage or contamination of the sample during the transfer. After fluid is introduced into a collection device as described by Mehl, an operator or technician may, at a later point in time, apply an evacuated tube to the Mehl device to withdraw an aliquot. Thus, transfer of an aliquot from the collection vessel requires an additional device, an additional step and generally skilled technical assistance. Even after the transfer is accomplished, the specimen remains suspect as the time interval between collection and specimen transfer can be variable and dependent on human efficiency.
One major problem not addressed by the Mehl patents, nor any other collection device known in the art, therefore, is the time lag between the collection of the sample and the analysis of the sample. Typically, this amounts to a period of days, or at least a minimum of several hours. During this period, the microbiological integrity of the sample can change significantly thereby causing inaccurate results. Due to the importance placed particularly on urine analysis for diagnosis of disease and a determination of the presence of foreign substances in the body, fair and accurate analysis and results are absolutely critical.
Since analysis of the sample immediately after the sample is taken is almost always logistically impossible, the alternative is to preserve at least a portion of the sample in the state in which it was taken. This can be accomplished by mixing a portion of the sample with a treating agent or chemical preservative of the type disclosed in a co-pending application Ser. No. 772,954 filed September 4, 1985 and entitled, "Stabilization of Specimens for Microbial Analysis," the disclosure of which is hereby incorporated by reference. Alternatively, it may be desirable to treat an aliquot of a specimen with another treating agent to produce a desired effect useful in analysis of the sample. For example, it may be desirable to admix a urine specimen to be analyzed for drugs or other chemical components with a reagent which will produce a colorimetric change if certain drugs are present, which will neutralize the pH of urine in preparation for further tests, or which will alter some other parameter of the urine specimen to suitably prepare it for analysis.
In order to ensure that a portion of the sample is preserved in the state in which it was taken, in certain instances, the preservative must be mixed with a portion of the sample immediately after the sample is taken. In other instances, immediate admixture with the treating agent is desirable even if not required. Although a portion of the sample could be transferred by hand to a separate container and mixed with the preservative, this would be cumbersome and would require the immediate attention of a nurse or the person collecting the sample. Typically, it would be difficult to ensure that such a transfer was done promptly, accurately, and aseptically. The present invention provides a device which overcomes this problem. A device is described that collects and holds a small aliquot of the specimen separate from the remaining portion and mixes it with the treating agent without requiring any extra manipulation by the nurse or the person receiving the sample. In addition, the present invention allows a larger portion of the collected specimen to remain unaltered by the treating agent, allowing for analysis for drugs, sugar levels, or other desired parameters. In the alternative, the larger portion of the sample may also be brought in contact with a treatment admixture suitable for other purposes, e.g., chemical or enzymatic stabilization.